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TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00608023
First Posted: February 6, 2008
Last Update Posted: April 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Theratechnologies
Results First Submitted: November 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Lipodystrophy
HIV Infections
Interventions: Drug: Tesamorelin
Drug: Placebo for Tesamorelin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tesamorelin (52 Weeks) Tesamorelin 2 mg/day for 52 Weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks) Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo-Tesamorelin (P-T) Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks

Participant Flow:   Overall Study
    Tesamorelin (52 Weeks)   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo-Tesamorelin (P-T)
STARTED   92   85   86 
COMPLETED   80   63   72 
NOT COMPLETED   12   22   14 
Withdrawal by Subject                8                10                7 
Adverse Event                1                4                5 
Lost to Follow-up                2                2                1 
Protocol Violation                1                3                1 
Unknown reason                0                3                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tesamorelin 52 Weeks Tesamorelin 2 mg/day for 52 weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks) Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo (26 Weeks) - Tesamorelin (26 Weeks) Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
Total Total of all reporting groups

Baseline Measures
   Tesamorelin 52 Weeks   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo (26 Weeks) - Tesamorelin (26 Weeks)   Total 
Overall Participants Analyzed 
[Units: Participants]
 92   85   86   263 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.7  (6.9)   48.9  (7.2)   48.4  (7.9)   48.3  (7.3) 
Gender 
[Units: Participants]
       
Female   9   9   11   29 
Male   83   76   75   234 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes From Baseline in Fasting Blood Glucose at Week 52   [ Time Frame: Baseline and Week 52 ]

2.  Primary:   Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52   [ Time Frame: Baseline and Week 52 ]

4.  Other Pre-specified:   Changes From Baseline in Triglycerides at Week 52   [ Time Frame: Baseline and Week 52 ]

5.  Other Pre-specified:   Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52   [ Time Frame: Baseline and Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information



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